Actively Recruiting
A Trial of "APL-9796'' in Adults With Pulmonary Hypertension
Led by Apollo Therapeutics Ltd · Updated on 2026-05-11
48
Participants Needed
6
Research Sites
129 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The AP13CP02 study is a phase 2, open-label, dose escalation trial to determine how safe and tolerable multiple subcutaneous (SC) injections of APL-9796 are for patients with PH. The study will also assess how effective APL-9796 could be for treating patients with PH and whether the body produces antibodies working against APL-9796. The trial will be conducted in two parts: * Part A: Up to 36 adults with WHO Group 1 Pulmonary arterial hypertension (PAH). * Part B (optional): Up to 12 adults with WHO Group 3 - PH associated with ILD (PH-ILD).
CONDITIONS
Official Title
A Trial of "APL-9796'' in Adults With Pulmonary Hypertension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be 18 to 80 years of age inclusive
- Diagnosed with pulmonary hypertension via right heart catheterisation at any time prior to screening
- WHO Functional Class II or III
- Participant has the CardioMEMS PA Sensor implanted
You will not qualify if you...
- Hospital admission related to pulmonary hypertension within 3 months prior to screening
- Major surgical procedure within 3 months prior to screening unless fully recovered
- Diagnosis of pulmonary hypertension due to HIV, portal hypertension, schistosomiasis, or uncorrected congenital heart disease
- History of left-sided heart disease or significant cardiac disease
- History of uncontrolled systemic hypertension
- Estimated glomerular filtration rate (eGFR) less than or equal to 30 ml/min/1.73m2
- Life expectancy less than 12 months as assessed by investigator
- Diagnosed with malignancy within 5 years prior to enrollment
- Contraindications to MRI or required diagnostic or sampling methods
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Hammersmith/Imperial Hospital
London, London, United Kingdom, W12 0HS
Actively Recruiting
2
Royal United Hospital Bath
Bath, United Kingdom
Actively Recruiting
3
Royal Papworth Hospital
Cambridge, United Kingdom
Actively Recruiting
4
Golden Jubilee Hospital
Clydebank, United Kingdom
Actively Recruiting
5
Royal Brompton Hospital
London, United Kingdom
Actively Recruiting
6
Sheffield Teaching Hospitals
Sheffield, United Kingdom
Actively Recruiting
Research Team
S
Sanjay Aggarwal, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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